Damien

Right, once again, well, good evening and a warm welcome to you, on our webinar on large prostate treatment. Now, my name's Damien, and I'm hosting this session. I'm delighted to be joined by our expert speakers, Mr Karl Spiteri, Consultant Urologist and Lucy O'Donoghue, Market Development Manager at Olympus.

Now, tonight's session will begin with a presentation from Mr Spiteri and Lucy, followed by a few questions at the end. Now, if you have any questions, please feel free to submit them using the Q&A icon at the bottom of your screen.

You're welcome to ask anonymously, or include your name. Just a note, though, that the session is being recorded, so if any names shared may be visible in the recording. To help us get through as many as possible, please keep your questions brief.

If you're interested in booking a consultation, we'll share all the relevant contact details at the end of the session. And let me hand you over to Mr Spiteri.

Mr Karl Spiteri

Hello, good evening. So first of all, thanks for joining us. I'm glad I was invited to give this presentation.

It's a presentation which will be focused on the symptoms and the management of enlarged prostate, which is a very common problem, but it's gonna have a heavy focus on an innovative procedure, which we have recently introduced here at Benenden Hospital, which is called the iTind procedure.

I won't talk about it much just as yet, because I'd like to go through a more generic presentation about prostate enlargement first, and then zoning onto the heightened procedure later on.

So, just very briefly about myself. I'm Karl Spiteri, I'm a consultant urologist, did all my training in both general surgery and urology in Malta. I then moved into the UK around seven years ago to train in robotics, robotic kidney surgery, which is my main specialty.

But of course, I also do lots of core urology. Which I practice both in the NHS and as well here at Benenden Hospital.

So, why are we doing this talk on prostate enlargement? Well, urinary symptoms are very common in men, and most of us might associate this with symptoms of getting old, but it is not always the case. It can be pretty common even in younger males.

And in fact, we are very known to suffer silently. Men typically leave it until it's very late before they seek help. But the truth is that effective treatment exists.

And as time goes by, we are seeing more and more modern procedures which are less invasive than ever.

This is just a bit of an overview of the webinar, so we're going to talk about the prostate itself, the enlargement of the prostate, what symptoms to look out for, when you should seek help.

And the various treatment options available, and as I said, we'll then hone in onto the iTind procedure.

Right, so, very briefly, prostate. It's a small gland which is located just beneath the bladder. We like to describe it as the size of a walnut.

And it forms part of the reproductive system, but as you can see on the diagram, the urethra, which is the water pipe, passes or pierces straight through that prostate gland, which is why it tends to be so related to the two urinary symptoms that men can experience.

Its function is mainly related to the production of seminal fluid and as you can appreciate on this screen already, how an enlargement of the prostate can constrict on that urinary tube, which passes right through it.

So, what is benign prostate enlargement? It's first of all, it's a benign condition. This is a non-cancerous growth, and I highlight this because Of course, I meet many patients who have lower urinary tract symptoms whose main concern is that there might be prostate cancer.

Now, actually, the very vast majority of lower urinary tract symptoms have nothing to do with cancer, they are to do with benign prostate enlargement.

it can be called various things, benign prosthetic hyperplasia, benign prosthetic enlargement, BPH, it's all the same thing, essentially.

And it's very common. It affects around 50% of men who are between 50 and 60. Having said that.

It's usually about 30% of men in this age group that actually have bothersome symptoms from it. So one can have an enlarged prostate, which gives no symptoms at all, which is fine.

It gets increasingly prevalent as we grow older, and in fact, it's estimated that about 90% of men older than 80 have benign prostatic enlargement.

Again, this is another visual representation to sort of depict How this benign growth of the prostate can cause a constriction of the urine that would need to pass through this tightened pipe over there.

But there's also what I call a dynamic component, so it's not if I go back to the previous slide, this is you can see the growth causing an anatomical obstruction. The growth is compressing, but there is also a dynamic component to these symptoms.

which relates to the to the musculature in the prostate and at the base of the bladder. So, if someone has a high tone of this masculature, it does cause a constriction around the bladder and neck, and what these little blue dots are representing are the intensity of receptors.

which will cause constriction of the smooth musculature in that area. And as you can appreciate in this image, there's quite a high density of them at the base of the bladder, which we call the bladder neck, which is where the bladder joins the prostate.

I wanted to highlight this slide, because when we later on talk about the iTind procedure.

This is an area which is particularly targeted by the iTind procedure, and we do see quite a fair few of men who have symptoms.

Whose problem is not so much the actual enlargement of the prostate, but more this tight bladder neck.

So why is it a problem? It's I already said this is a benign condition, so why is it a problem? It starts off as a bother, and it tends to remain a bother for quite a long time, but slowly but surely, it can lead to more sinister or difficult problems, such as chronic retention of urine.

And a more end-stage result is having obstructive kidney failure when if one had to reach a stage where the bladder is just constantly in retention and causing back pressure onto the kidneys.

But there's also an important aspect, which is bladder dysfunction. So, imagine This bladder, which is constantly having to generate a high pressure to squeeze urine out through that enlarged prostate.

Over time, this bladder is going to become increasingly dysfunctional, so causing lots of frequency and urgency and kind of contracting on its own accord. And this is something that is not easy to reverse.

So, we have changed our notion nowadays, where we don't really like to allow things to be too far gone. There is a sweet spot where one needs to have an intervention so that one can prevent having these more reversible bladder problems.

What are the symptoms that one would get? So, the earlier symptoms tend to be a reduced or a poor flow.

a difficulty in starting the piece, having, like, kind of having to wait a whole minute before the P actually starts.

And, getting more and more have a need to strain, to squeeze that urine out.

As time goes by, then, there tends to be more of these what we used to call the irritative symptoms, so waking up to pee at night all the time, lots of frequency of urination, and having a really urgent need to pee. Once the signal comes, you just have to go.

And also difficulty to fully empty the bladder.

And how might this affect one's life? Of course, it can result in lots of disrupted sleep, poor rest.

What we see a lot is people planning their life around toilet availability. Of course, anxiety when traveling. And it can even have an impact on work and relationships.

So, when should one seek help? I think one of the more important things is the first dot there, if the symptoms are bothering you, because effective treatment exists.

As I said, these are benign conditions, so if the symptoms are particularly mild, and they're not bothering you, yes, they can be left alone, and perhaps with some lifestyle modification, you can avoid medication and even avoid surgery altogether.

But especially if there are progressive symptoms, and even more so when the symptoms are progressive from those earlier-type symptoms that I mentioned, to the more irritative-type symptoms, the frequency, and the urgency.

I think that would be the time where you're willing to start thinking of seeing whether you need to have something done.

And again, the big notion here is to protect the bladder from having long-term damage.

From years and years and years of unmanaged symptoms.

Other reasons to seek help is if there's recurrent infections, which can be associated with an incomplete emptying bladder.

And also, visible blood in the urine. I mentioned it's not a direct symptom of benign prosthetic enlargement; it's just one of those symptoms that we never ignore. Visible blood in the urine, that's something that needs to be seen, too. So I always like to mention that.

And it's not too complex to diagnose and do a workup for prostate enlargements, and it can it's something that can be easily done as an outpatient, and it is something that we routinely offer here at Benenden.

So what would you expect if you are referred for these symptoms? First of all, we take a detailed history about the symptoms and how these are affecting you.

It's quite common that we do a digital rectal examination to get a bit of a gauge of the size of the prostate, but also it's a good screen for any overt prostate malignancy.

We quite routinely do a urine dip test, and a urine flow test, and also a bedside ultrasound to assess how well one is emptying the bladder.

We do not always do a PSA, and we do not always do a cystoscopy, but they are quite common investigations that we do as well, so you will be guided by us whether you need these or not.

And what are we looking for? The severity of symptoms? Are there any signs of back pressure on the kidneys?

We try to establish whether this is mostly a prostate or a bladder issue. We also want to understand whether there's any prostate cancer underlying, but importantly, we need to understand your wishes, priorities, and expectations.

Also, we then need to find out which treatments are the most likely to work for you. So, this is where we start looking at the specific anatomy in your particular case, and the particular physiology in your particular case, to counsel you about the procedure which is the best one for you.

I'll briefly go through this. So, there's, Various things that can be done, so lifestyle modifications, then, sort of.

We escalate to medications, and then it can be escalated to surgical intervention. And as we will see, there are the more classical radical interventions, and nowadays there's a couple of minimally invasive options.

And there's a various amount of factors that we use to guide you as to which one you should undertake, including the symptom profile, the anatomy of your particular prostate, but also your wishes and your priorities.

So medications are very well established. We used to consider these the first line. There's the alpha blockers, which relax the bladder, neck, and the musculature in the prostate. And there's also finasteride, which shrings the prostate. But of course, these would be long-term medications, and I meet quite a lot of men and understandably unkeen to be on long-term medication, or they have tried them, and they have too much side effects, or the other thing that can happen is they start to work initially, but then the symptoms progress and they're not working anymore.

The more radical surgery, I use the term radical loosely here, this is not some barbaric surgery, it's radical compared to the more modern, minimally invasive ones.

But since there's the transureter resection of the prostate, where we physically core out that obstructive internal prostate tissue.

There's the laser enucleation, which does the same thing, but in a different way, and it's designed for those particularly large prostates.

There's also the aquaablation, which is a more modern way of removing that obstructing tissue, using a high-powered water jet, and that is actually something that we also offer here at Benenden Hospital, so all these three procedures are available here.

They are very effective, because these are literally removing chunks of tissue from the prostate, and they have stood the test of time. They're durable, but of course, being more radical, they come at the expense of other potential effects of having removed all that tissue.

So there's quite a high rate of retrograde ejaculation, which means that when one has an orgasm, there's no seminal flu being ejected. Essentially, it goes back into the bladder. Completely harmless.

Quite a few men are not bothered by it, but other men are quite sensitive to the loss of ejaculates. So this is something that we do factor quite seriously now that we have other options.

I should mention at this stage that even though the more radical surgeries are associated with a high rate of retrograde ejaculation.

The Aquablation is one of the more disobstructing procedures that actually has a higher chance of preserving retrograde ejaculation, so I need to specify that with Aquablation, there's a higher chance of protecting that.

They are associated with an inpatient stay, and most of them need a temporary catheter, and of course, there is a higher risk of bleeding and a higher recovery time, because it's more radical surgery.

And this now leads me on to the minimally invasive procedures. I've listed these two, because these are two that are offered here at Benenden. There are others as well, but it will be a whole night of talking if I had to go through each and every procedure.

So the Urolift is also a procedure which has stood the test of time. It's the one it's the procedure, which is represented by the diagram that you are currently seeing, where it involves permanent implants, which essentially pull the prostate lobes apart to open up that channel.

And the other minimally invasive procedure, which will be the highlight of today's talk, is the iTind procedure.

Which I will start talking about now, and this is a slide I like a lot, because It depicts how iTind is kind of designed to hit a sweet spot between not being too invasive.

But, not doing anything at all. So, as you can see on the left-hand side of the screen, there's watchful waiting, which means when we decide that we are going to tolerate the symptoms as they are, and just bide our time.

escalating to medication, and eventually all the way up to the permanent implants and the more radical surgical options. And iTind is designed to be there right in the middle for people who do not want to be on medications, but either don't have Sort of severe enough symptoms for a more radical operation, or are not ready to have that more radical procedure.

So, what is the iTind procedure? It's quite an innovative way of of opening up the prostate, so it uses this Like a cage, made of, made of wires, and it is placed in the prostatic ureter as depicted in the image here.

It's deployed into the prostate, as a day-case procedure, and it then stays there for around a week.

And whilst it's there, those three lines of wire will start working their way into the prostatic tissue, and slowly but surely, they will reshape the prostate.

So that they it will it will afford it a much wider channel for the urine to passes.

After a week, the device is removed, and once the device is removed, there's quite rapid relief of symptoms, without requirement for any permanent implants.

And, as it's written there in the text, there's no cutting of tissue, no burning, no destruction, so it's a quite sleek way of opening up the prostate.

I put this image here just to see to show you how it looks after the device is removed. So you can see on the first image when it's first introduced, the second image is then showing how it works its way through the prostatic tissue to open it up, and then it's removed to leave that, open channel here.

I have a similar slide, which I'll I just want to highlight that What is quite different in this iTind procedure compared to the other is that it does quite a lot of work at the bladder neck, and you might remember I showed you that slide earlier on where quite a few men have an issue not so much with the prostate enlargement as itself, but with a tight bladder neck. And this is a procedure that can really directly target that tight bladder neck.

And replace the need for long-term medications that relax the bladder and neck.

This is showing the same thing, but in a cross-sectional view. So you can see on the image on the left.

The constricted urethra with tight bladder neck, and after a week of implant, those three wires will open those 3 channels into the prostate tissue to allow the urine to pass easier.

And this is more of a real-life image now, showing the end result of those incisions that the device would have done over the course of that week.

So, as an overview, the iTind device was innovated and designed to specifically give a rapid symptom relief.

With a rapid return to daily life, and preservation of sexual function. By sexual function, again, what I refer to here is the maintenance of the anti-grade ejaculation, so that one doesn't lose the ejaculate.

And also, of course, designed to support durable results and specifically designed to avoid the need of a catheter following the treatment.

Designed to avoid, or getting off prescriptions, for long-term medications.

It is designed to avoid general anesthesia. Having said that, the insertion tends to be done under general anesthetic.

We are looking at eventually getting the insertion done also under a local anesthetic, so that both the insertion and the removal are done under local anesthetic. And again, is designed to avoid sexual dysfunction and designed to avoid the need for permanent implants.

In medicine, we are quite fixated about having evidence about all we do, so I thought I'd present some evidence about this device to support its use, and why we've decided to start offering this procedure.

I'll start by presenting this, one of the earlier studies which was done so it was a what we call a prospective study, which is sort of gives a higher quality evidence.

And that showed that, over the course of 2 years, you can see this graph depicting the improvement in the flow rate. So, generally speaking, the flow rate doubled following the heightened procedure.

And, I mean, as urologists, we're all, we give lots of importance to the flow rates, but actually, from a patient perspective, perhaps what you would be more interested in is not necessarily the number, the flow, but actually how it's affecting you. So this is perhaps an even more important slide.

IPSS is the International Prostate Symptom Score, which essentially, it's a scoring system which covers a myriad of symptoms relating to the prostate. So this is what really will be affecting you on a day-to-day basis.

And, as you can see, the symptom score effectively halves following the insertion.

Of the device, and over the course of the two years when the study was performed, the results were sustained, which is quite important.

Again, similarly, this is a quality of life score. The higher it is, the more terrible it is, and as you can see, with the device, it went from an average of four to an average of two, and it was quite well sustained over those two years. So this was one of the earlier studies.

Of course, as time went by, we got more and more data so that we can get a better idea of its durability.

I've got this next, so this is just showing the volume which, as you can see, has also gone down. This is the amount of urine that remains in the bladder following a urination. You might note that it was not too high to start off with.

And the reason for that is people who have a very high urine residual are not ideal candidates for iTind in the first place. So that's why it was not too high to start off with, but as you can see, it went down following the iTind insertion.

So this is the slide I was referring to, which is now showing the trials, but, after four years, because, of course, we got very excited with those two-year data, but we wanted to see how long, how durable, these effects are going to be.

And, actually, the improvements were sustained at over 4 years, and actually, I don't have the slides here with me, but there's newer data showing that the benefits are sustained even up to six years. And as time goes by, we'll have more and more data to see how fair their durability is going to be.

The other reason I wanted to show this slide is that it is showing, side by side, different trials. So this is not just one trial, but there are here are three different trials, which were done independently, all of them prospective and all of them multicenter.

And they're pretty much showing similar results across the board, so improvement in the symptom score, and improvement in the flow rates, which were sustained.

So, what would you expect from an iTind procedure? Mentioned some of these, so it's inserted as a day case procedure. It's removed as a day case procedure a week later. No cuts involved, no stitches, quick return home.

I would need to highlight that during that week, it will be uncomfortable, yes, because there is going to be this device which is pressing internally on your prostate.

So, I would suggest that if one is having such a procedure, you would stay probably best to stay off work for that one week while the device is doing its job, but then once the device is removed, within a few days, literally, you're up and running again.

And as I said, there is no requirement for a cater in the very vast majority.

So the key benefits, it is minimally invasive, truly minimally invasive.

There's no permanent implants, rapid recovery, rapid symptom improvement.

Now we can say that they are also durable improvements.

Importantly, preserve sexual function.

And no need for a post-operative cater.

To be completely candid, the rate of categorization after items is around 5%, so that's pretty low.

Regarding safety and side effects, I've already alluded to the fact that once the device is doing its job, it's gonna be pretty uncomfortable, and you'd need to be at close proximity to the loo for that week.

So there will be short-term urinary symptoms whilst the device is doing its job.

But he has very low complication rates, very low cauterization rates, and understandably, the symptom improvement is going to be less dramatic compared to the more radical surgery. And this, I mean, this stands to logic, because of course.

The more radical procedures are physically removing whole chunks of tissue from the prostate, so you cannot compare a minimally invasive prostate procedure to the more radical ones. They're just two different they're achieving different things.

So, if one has very severe symptoms, or his bladder is already having dysfunction, lots of urinary retention then iTind is not the procedure for you. In that case, we'd be advising to have a more radical procedure.

Yeah, so who is suitable? People who have mild to moderate symptoms.

What we call smaller prostate, so what I mean to say here is that the prostate enlargement is a progressive thing, and someone who has, say, a, I don't know, 30 gram prostate, that's, for us urologists, is considered a small prostate compared to the huge ones that we tend to see. But it is still an enlarged prostate compared to when one is younger.

It's suitable for people who want or need a rapid recovery, a rapid return to their daily routines.

People who are seeking an alternative to long-term medication to manage their prostate symptoms.

Suitable for people who want to preserve their sexual function. Again, by this, I refer to preserving the ejaculatory mechanism.

People who prefer to avoid a catheter after the procedure, and people who have a good baseline bladder function. So this is not designed for people whose symptoms are already too far gone.

And in fact, it is unsuitable for prostates which are just too large.

Prostates which have a middle lobe, this is an anatomical detail, which we assess when we do a camera test of the prostate.

And it is not suitable for people who have established bladder dysfunction.

So why would one choose to come and see us here? We're a group of very experienced urology consultants, we work very well together, and we have access to the latest technology, including iTind, which I've now spoken much about, and also aqua ablation.

We value a lot giving personalized care, and especially when it comes to prostate, because as I mentioned earlier in this talk.

Quite a lot of it has to do with how the symptoms are affecting You in particular, how they're affecting your life.

And of course, there are shorter waiting times, over here at Benenden.

So, if I had to sort of choose, like, two key takeaway messages is that BPH is very common, but it is treatable, and the iTind offers a minimally invasive option, which works well, durable, but preserves your sexual function.

So yeah, sorry, I've been babbling for quite a long time. I think now is a good time to hand over to my colleague, Lucy, from Olympus, who's been has helped us out to introduce this new procedure here at Benenden.

Lucy O’Donoghue

 Yeah, so thank you, Mr Spiteri, and to Benenden Health for having me here this evening. I'd be pleased to share with you some real patient experiences of having the iTind procedure. I work for Olympus, which is the company that sells and supports the use of the iTind device here in the UK.

So firstly, I just wanted to acknowledge the patient's journey. Many will have been managing their symptoms for quite some time. We often hear about frequent trips to the bathroom, especially at night, disrupted sleep, and that constant feeling of urgency. And also, of course, the emotional side, the fatigue, frustration, and sometimes even embarrassment.

And that can really have an impact on people's daily routines, their social activities, and their overall quality of life. And in my role at Olympus, I've had the privilege of hearing some of these patient stories, which I would like to share with you this evening.

There are three of them. This is the first gentleman; his name is Chad. He's a 44-year-old man from Liverpool, and he generously shared his story with us, which was then featured, as you can see, in the Sun news outlet. Chad was diagnosed at just 28, so he had been suffering for a long time. He learned that his father had suffered from the same condition, and so he went to see his GP about it.

Chad said that, Over the years, I tried medication to improve flow, but it felt like sticking a plaster over a larger wound.

Helpful for a short time, but the less effective the longer I took it. He also had a surgical procedure called a bladder neck incision, which is where cuts are made in the bladder neck to relieve the obstruction. But again, it didn't provide him with lasting relief.

Sleep was his main issue, and he said it became an endless cycle. That level of exhaustion wasn't sustainable, especially with a high-focus job. I reached the end of my tether, and I knew I needed something that really addressed the problem.

So, Chad underwent the iTind procedure, in a hospital near Liverpool. He said, Before I could be discharged, this is after having the procedure, I had to empty my bladder. The flow shocked me in a good way. I hadn't experienced anything like that for years.

He also said that he understands why some men hesitate because of the intimate nature of the exam and the treatment, but he said he was treated with absolute dignity and professionalism throughout, and any initial embarrassment quickly gave way to feeling safe and cared for.

And he concluded by saying, if you're experiencing similar symptoms, don't put it down to pride, or assume it only happens to older people.

There's no shame in asking for help. Be in tune with your body, speak to your GP, and find out what options exist. You don't have to manage this alone.

The second gentleman is a GP. He's 58 years old, and he doesn't wish to be identified due to the nature of his work, so we'll call him John, and this isn't his real name, and this is not his image either.

John said that at night he was having an urgent desire to urinate on a very frequent basis, almost every half an hour to an hour. I would have to get up and go to the toilet, and I wouldn't necessarily pass much urine.

This was having an enormous impact on his life and work, because I'm a GP, and it was disrupting my clinics.

His symptoms really disrupted his life, sleep, and working hours. Working in the medical field, he said that he knew there was a problem from the beginning, but he continued to struggle with the symptoms for about 10 years.

He said, I was reluctant to take any medication. I have patients myself who react to lots of medications, or are hesitant to take anything, and I'm sort of like that.

But 8 years into his suffering from BPH, he did try medication, but he found that it didn't particularly help, so he decided he wanted to consider some surgical interventions. He discovered that he could be a good fit for the iTind procedure.

He said that the great advantage of the iTind procedure, compared to other options, was that it was a temporary device. The device would only need to stay in for about a week.

It's a really low invasive procedure. I also didn't want to stay in hospital overnight. I didn't want a catheter afterwards. Plus, there's a low risk of incontinence with the iTind. I just thought all of that sounded perfect.

John underwent the iTind procedure.

He said that as soon as I had the procedure, I noticed an improvement. My flow rate was much better. I was emptying my bladder within 30 seconds compared to the prolonged time before, and this has been maintained.

He said that he was completely fine after having the iTind removed. He remarked that he was advised not to ride his bike for the first week, but he could go for runs, and he was pleased to be back on his bike the following week.

When asked if he would give any advice, he said, by going to your GP, You will be able to find out much more, as well as the options available. I would also say, if you're thinking about having surgery for this condition, inquire about the iTind and see if there's something they think could be helpful in your case. I also encourage patients to seek help.

Partly because most people do not know or can't always tell the difference between BPH and prostate cancer and other conditions.

He goes on to say, I truly do not know if I would have gone forward with any sort of surgery. My other option was to have an incision on my bladder neck with a scalpel, and then come out of the hospital with a catheter. It's definitely worth trying the iTind, because if it doesn't work, then I'm sure there are options. But I do think this is a brilliant non-invasive option.

And finally, this is Mark. He's a 66-year-old from Hampshire, and he's a retired pharmaceutical marketing manager. He owns a camper van, and he likes to volunteer with Oxfam at summer festivals. He first noticed a problem with his prostate in his mid-50s. He used to wake every hour or two at night to pee.

He needed to be near a toilet at night with a clear walk from the toilet to his bed, which isn't ideal, as you can imagine, at a festival in a muddy field.

It also meant that nights away from home, staying with his parents, overnight with his friends, he had this extra layer of stress.

And it also impacted his relationship. He'd often wake his wife at night because he was restless.

Also, he felt it was embarrassing for her sometimes, as he often needed the loo, frequently when they were out and about.

He took Tamsulosin, which is a BPH medication, and it worked well in the beginning, but as the years went on, he began to struggle with dizziness, which was quite worrying for him.

So, he went to see his GP, who referred him to a urologist.

And he underwent the iTind procedure.

Mark said that it was uncomfortable for the week that the iTind was in. He said that he had to take painkillers and be near the loo constantly, but once removed, the discomfort disappeared within a day or so.

I was able to go on holiday two weeks later.

He was very satisfied, saying, I rarely have to go to the loo more than once a night now, and sometimes not even that. So I sleep better and I'm more rested. He concluded, I'm looking forward to not having to wade through a muddy field in the night to get to the toilets.

So, these issues can carry a lot of fear, and that can stop men from seeking help, but the condition's very common, not just in older men, but in those even in their 40s and early 50s. But it is treatable, and there are now less invasive options, such as iTind, which takes around 15 minutes, with no overnight stay.

So our message is to know your flow. If something doesn't feel right, when urinating, I encourage you to speak up to your friends, family, or doctor to get it checked. And if I tinned, If your doctor thinks that iTind could be suitable for you, as Mr Spiteri described, there are benefits in increasing your quality of life, providing quite rapid symptom improvement. It's quite a straightforward procedure, and has been shown to preserve sexual function.

The results have been shown to be durable, and it is routinely catheter-free.

So with that, I will hand you back to Damien. Thank you for your attention.

Damien

Lovely, thanks, Lucy. Really interested to hear those cases, and thank you, Mr Spiteri as well, for that for that initial presentation.

What we're going to do, we're going to move over to the questions, the Q&A session now. We're really pleased to see so many of you today, so we're going to answer as many as we can. If we don't get through all of them, if you've left your name, we will get back to you via email after the event.

So, actually, during your first presentation, Mr Spiteri, Keith was quite quick to ask a few questions here. First, he actually wanted to know what cystoscopy was.

And then, second to that, whether the iTind could resolve his urgency issues.

Mr Karl Spiteri

So, in fact, I should start by apologizing for not saying what a cystoscopy is. Yeah, cystoscopy is a it's a diagnostic procedure where we use a telescope that goes through the P-hole so that we assess The urinary retract from the inside, so we assess the urethra and the prostate and the bladder from the inside.

We do this quite commonly for people who have lower urinary tract symptoms from a large prostate that we think might need a surgical intervention. And the reason we do it is, as I said, there's Quite a big variety of options nowadays.

And we would seek to identify which intervention would be best suited for for you, for your symptoms, but also for your prostate. So, looking literally at the anatomy of your prostate to see which one is the most likely to be of benefit to you.

Regarding the second question, does iTind resolve the urgency issue? The answer is yes, but there's some key issues here, so regarding when it comes to the urgency of urination, this can happen as a result of an enlarged prostate and the subsequent effects it has on the bladder.

But it is not uncommon for people to have frequency and urgency, not because of a prostate issue, but because of a primary primarily bladder problem, where the bladder is hyperactive, overactive and in these latter circumstances the interventions to the prostate tend to not do so much for the frequency and the urgency. But if these are if frequency and urgency are as a result of the obstructive prostate, then yes.

The iTind, and similarly, the other procedures, not just the iTind, will improve the urgency.

What I always like to highlight is that when we have whatever procedure we do, not just the IT and even the others, we typically see that the flow is the flow rate and the ease of urination is the first thing to improve.

The frequency and the urgency tend to lag a bit behind, and in fact, it's not uncommon for the frequency and the urgency to become a bit worse before they become better, because this long-term obstructed bladder all of a sudden has its obstruction taken away, and you're left with this unopposed overactive bladder. And it takes a couple of weeks for the bladder to readjust to that.

Damien

Yeah, fantastic, thank you. So, we've got a few similar questions here. Maybe you could remind us as to how long we believe the iTind can last, but on top of that, whether the procedure could even be repeated.

Mr Karl Spiteri

Yes.

So, as the years roll by, we are getting more real-life data to show us that the item is indeed durable, and this is very important to us, because as I said earlier, we know we can't compare a minimally invasive procedure to a more radical one. The radical ones, we know, they can last for even decades, sometimes even two. But so far, we have data of up to six years, which is showing that the results are indeed durable.

Of course, there's no guarantees. A minority will need either repeat intervention or perhaps a more radical procedure down the line. And this is the reality with the minimally invasive procedures. They do improve symptoms, but the improvement is not as dramatic as the more radical procedures, and yes, it might be the case that later on down the line, you might need either a repeat intervention or potentially a more radical procedure. Can it be repeated? Depends. I mean, let's say the symptoms Start progressing again, and they're they become a bit too much.

We would need to redo the investigative process, including the cystoscopy, to see why the symptoms have recurred, and if it's something that if it is we find that the item can be repeated, yes, well and good, but if we find that actually the prostate has just continued to grow all over the place.

We might probably be telling you, listen, there's no point repeating the items. Now is the time for you to have a more radical procedure.

So that's something I stress quite a lot, that the iTind and the other minimal, not just the iTind, but even all the other minimally invasive procedures, they are not for everyone. It depends a lot on the symptom profile and the anatomy of the prostate as it is.

Damien

Lovely, thank you. We've got an anonymous question here. This gentleman's been prescribed, Tamsulosin 400mg released by capsule, but they seem to have no effect, and he's still urinating frequently. Should he stop taking them? He's been on those medications for a year now.

Mr Karl Spiteri

Well, this is actually a very common scenario that we encounter quite a lot.

My take on this, first of all, you should always seek, sort of, advice from someone who knows your case in much more detail. I can't give formal advice based on a one-liner. But, just to give you a general idea, my take on this situation is that If a medication is making absolutely no difference, then there's no point in taking it, especially if this is for a benign condition.

Where the aim is to improve the symptoms.

Having said that, it is not at all uncommon that people who feel that there's no benefit at all when they stop taking when they then stop the medication, they feel that actually things are even worse than they were. And this is normally because the prostate enlargement is a progressive thing, and The Tamsulosin, even though you might feel that it's not doing much, it might be slowing down that progression.

So, what I usually advise in these situations is that, I mean, if you've been on it for a year, and it has made no difference at all, you can try and come off them. It's a short-acting medication, so within a week, even less.

you will know whether there's a difference or not. And if you find that on stopping the medication, you know worse, then the answer is easy. Don't take them.

Whereas if you find that things have actually become even worse than they were, you probably ought to continue them, but you may or may not want to seek advice on Having other medications or surgical intervention, because the medications are not enough.

Damien

Yeah, absolutely. Perhaps maybe we'd be seeing that gentleman in the future, in the future. So William's asking William's also on, on a form of medication recommended by one of our colleagues here. He said that it's for a, if he's nocturnia worsened by the next step would be TERP.

Do you think it's likely that his benign prostate has gone beyond the option of less invasive things like the, like the iTind?

Mr Karl Spiteri

Yeah, it is possible. Again, I can't judge by by by so little information, obviously. But this is something I was trying to allude to earlier, that's iTind is not a magical solution for everyone. If the symptoms are too far gone, there's bladder dysfunction, there's lots of urinary retention, we ourselves would be telling you a minimally invasive option is not is not good for you. It's not just going to work. And in that case, you would need a more radical procedure, such as TURP. And I know, I mean, I've been praising iTind, but I will be very honest in saying that all the other options they're also very good. These are all very good options. The UTRP, the Urolift, there's plenty of options. It's just finding the one which is the best for your particular situation.

Damien

Lovely, thank you. We got another anonymous question here. Oh, and this is an interesting one. Can the iTind be performed after the UroLift, which was actually performed about 5 years ago for this gentleman?

Mr Karl Spiteri

Yes, it can. I mean, the iTind, there's a is a sorry, the Urolift is a permanent implant. But I don't see why the item shouldn't work if there was a previous Urolift.

Assuming that the anatomy is right for an item.

Lucy, can I ask you to intervene on this one? Am I correct in stating this here?

Lucy O’Donoghue

 Yeah, so, the company I work for, Olympus, has not run a clinical trial using patients who've had Urolifts and who've had a, you know, not enough of an improvement in symptoms and who want something else to then have an iTind to say that it works. So I suppose from my perspective, we can't advise that it will work, and then we would sort of pass it over to your clinical expertise.

Damien

If the gentleman's attending, there's, you know, symptoms are coming back, take advantage of the offer and come and see Mr Spiteri, I guess would be probably the best advice, do you think? And we can take us from there.

Mr Karl Spiteri

Yeah, yeah, yeah.

Damien

Okay, great.

Mr Karl Spiteri

It's a very niche situation. There's not going to be any trial specifically looking at that specific situation. So it would boil down to clinical judgment and having a look inside, and making a clinical decision.

Damien

Okay, great. Jeff's actually got a question here about aquablation, and this is whether he could actually drive himself home after the procedure.

Mr Karl Spiteri

I mean, not immediately, because it involves a general anaesthetic, and you shouldn't be driving yourself home immediately after a general anaesthetic.

So, typically, you would stay the one night after an Aquablation, and I would still generally recommend that someone drives you home the day after the operation, but technically, yes, you can, technically.

Damien

Okay, great. And actually, I hadn't noticed this second question from Jeff, and I think this is quite an important one across the different modalities, is there an age limit for any of the procedures, or is it just determined by general health?

Mr Karl Spiteri

Very good question, and I would very much view towards the latter, which is general health.

Of course, we do look at age. Age is an important factor, but there's what we call the age, and then there's the physiological age. So, we see people who are in their 80s and 90s who are super fit, fitter than myself, and their physiology is really great. Equally, we see people who are 50 years of age who have, unfortunately, terrible comorbidities, and they don't do well with surgical intervention. So, the general health, I would say, is even more important than the absolute age when determining whether one can withstand or do well with a surgical intervention.

Having said that, even the fittest of elderly people. The reserves, the physiological reserves, are not as good as they used to be when one is younger.

So this is still something we factor in, okay? Because, you might be as fit as a fidel, but following an intervention or a general anaesthetic. You one would struggle to recover compared to someone who's younger.

I would have to say that this is where the benefit of these minimally invasive procedures comes to the fore as well, because they are minimally invasive, the tissue trauma is less, they're short procedures.

So, there tends to be a quicker, better recovery for people who have more limited physiological reserves.

Damien

Lovely, thank you. We've got Keith asking again, a good question, Keith. So, for the 5% who do require catheterization, and this was related to the iTind, how long would that be required for? I don't know.

Mr Karl Spiteri

It is not permanent, luckily so essentially, in the unusual circumstances where this happens, we we can introduce a catheter through the device, so device would be their implant, and then we just put the catheter through it, and it's a temporary catheter.

Until the swelling and the inflammation settles down, and then we take the catheter out. So, it is not a permanent cater. I would say it would probably if that happens.

We'd leave it for the week whilst the implant is doing its job, and then we take it out at that stage. But it's no, it's not permanent.

Damien

Lovely, thank you. And an anonymous question here, do we get to choose which procedures we have?

Mr Karl Spiteri

To a significant extent, yes. So, what we do is we do that full assessment that I spoke about earlier, take the history, we do the cystoscopy, we do the flow rates.

And based on all those, we will then narrow down the options for you. Now, there will be occasions where we'll tell you, listen, there's this this is the procedure for you, this is the if you're going to have something, this is the one that you should do.

But it is quite common that we tell you, actually, based on your symptoms, your anatomy, you can have this procedure, or this procedure, or this procedure. This has these benefits, this has that benefit, and we then allow you to choose which one you'd like to proceed with.

Damien

Lovely, thank you. Mike's got a couple of questions here. So, firstly, he wanted to ask whether the iTind surgery was under a general anaesthetic, but secondly, he was inquiring about whether MRI is ever used in the part of the diagnostics.

Mr Karl Spiteri

Sorry, yeah, good question. So, regarding the general anaesthetic.

The insertion, yes, it's done under a short general anesthetic.

But we are very keen that we then we are looking at shifting that into a local anesthetic insertion. To be very candid, we're quite keen to get more, sort of get more fluent, because this was quite a new procedure. And once we get even more fluent with it, I would be very keen if we start doing the insertions under a local anesthetic as well.

But currently, the insertion is under a short general anesthetic.

The second question regarding the MRI, not routinely, no. So, we don't routinely do an MRI as part of the diagnostic workup.

We do recommend an MRI if we have some suspicions, or we want to rule out prostate malignancy. That's where the more the power of an MRI is, to look for prostate malignancy.

So let's say we do a digital rectal examination once you're in clinic, and we feel a bit of a nodule which you need to look into further, or the PSA is particularly high, then yes, we'd include an MRI as part of the diagnostic process, but it's mostly To to confirm or rule out cancer, rather than as part of the workup of the lower urinary tract symptoms.

And regarding the bladder scan, that is essentially a bedside ultrasound, where we measure the amount of volume of urine that remains in the bladder after having a pee, to see how efficiently the bladder is emptying.

Damien

Okay, lovely, thank you. John actually asks, why does the prostate return oh, sorry, why doesn't the prostate return to its original shape after the iTind removal?

Mr Karl Spiteri

So, in fact, the way the device was designed is so that it doesn't return to the original shape. So, those three Metal wires will be applying a constant pressure so that they slowly but surely cheese wire over the course of a week through the prostate tissue.

And because you're not just, you know, just slicing through deposit, that doesn't just reheal and close it back up. The fact that it keeps on cheese wiring over the course of the week, it essentially remodels the prostate, so it retains the shape that the items does.

Damien

Okay, great, thank you. You might have a better idea of off-the-cuff anatomy like this for David Smith's question here. Can iTind be suitable for a prostate five times bigger than normal?

Mr Karl Spiteri

I would say no, unfortunately, because it again, it depends what you classify as normal. Yeah, well, yeah, but Let's say when we are very young, the prostate is about 20cc, so 5 times as larger, implying 100cc prostate, which is not suitable for an item, no.

Damien

Okay, lovely, thank you.

We got Mike here. How many patients were surveyed to give the results of the success of the treatment?

Mr Karl Spiteri

I think there was quite a few different studies there, I don't know. Yes, there's quite a few. I think the perhaps the more the one I spoke about the most, and the one which has those durable which show the durable results over, over the years.

The number of people which went through the entire follow-up, because people drop off, of course, during these studies, people unfortunately die of other things, or they just don't follow up. But I think it was 48 people, which were followed up up to 48 months.

Damien

Yeah, no, fantastic.

Oh, excuse me.

Yeah, Kevin's asking, have I sorry, I have been taking various medications again for 5 years now. If I had the iTind, could I stop taking these medications?

Mr Karl Spiteri

Yes, in fact, that is one of the reasons for the iTind. It's for people who are on medical management of the prostate, who and either the medicines are not working enough anymore, or they'd like to come off the medications.

So the answer is yes, assuming that the diagnostics show that iTind is the right procedure for you.

Again, depending on the symptoms and the prostate anatomy.

Damien

Fantastic, and I think we've got time just for one more, because This might actually relate to a new procedure here that has just been introduced as of a few days ago. And this gentleman is asking, can iTind be carried out on an 84cc enlarged prostate, and how does the operation compare to a HOLEP laser?

Mr Karl Spiteri

Yep. So, again, I would say that 84cc is a probably a bit too much for right, and it's unlikely to work with a native force, you see.

And, for that size of prostate, again, depending on other factors, but generally speaking, it's gonna be either a TURP or an Aquablation, or, in fact, the HOLEP procedure.

So, the whole procedure, essentially, I won't steal it under, because it's, as Damien said, this is a procedure that's sort of now newly being introduced here, but essentially it uses a laser to enucleate all that internal core of obstructing tissue. So this is designed, sort of, to maximize the amount of tissue removal to really get a really big wide channel.

So it's particularly suitable for the very large prostates, including 84 cc's, but, you know, HOLEP would be suitable even for prostates which are 150cc, 200 cc's, you know, these sort of big, big prostates.

8 to 4 cc's, hole up is a good operation, but equally could have a TORP or an Aquablation.

Damien

Good, good, good. No, it's good to hear that we've got such a large portfolio of procedures and offerings that could cover pretty much, or not, almost everyone.

All right, grand. Well, thank you, everyone. Thanks again for your questions and being part of this evening's session. If we haven't covered your question, if you've provided your name, we'll follow up with you via email. As a thank you for attending, we are pleased to offer 50% off the value of your consultation.

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Finally, thank you for, both our guests here, Lucy and Mr Spiteri, and good evening to you.

Thank you very much, and good evening.